Non Coeliac Gluten Sensitivity in Children

Diet, Gluten-Free Clinical Trial

Official title:

Does Non Coeliac Gluten Sensitivity (NCGS) Exist in Children? A Double-Blind Randomized Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895438
• Other study ID #: 1408204
• Secondary ID: 2015-A00060-49
• Status: Completed
• Phase: N/A
• Start date: May 27, 2015
• Est. completion date: November 22, 2017

Study information

• Verified date: October 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Irritable Bowel syndrome (IBS) is a very frequent condition in children. Its management is difficult, often resulting in a persistence of chronical abdominal pain.

In adults, many patients affected by IBS improve under a gluten-free diet, even in the absence of Celiac Disease (CD) or wheat allergy. This condition is called Non Coeliac Gluten Sensitivity (NCGS). However, it is still not clear how to diagnose and manage NCGS, and the pathophysiological mechanisms also remain elusive.

The aim of this study is to determine if NCGS exists in children with IBS and to identify the clinical, serological, and histological characteristics, which could distinguish patients with NCGS from conventional IBS and CD patients.

This is a prospective cohort study in a population of children affected by a moderate to severe IBS for more than 6 months. All children had a Gluten Free Diet (GFD) for 6 weeks. Then, children who improved under GFD were randomized in two groups for a double-blind placebo-controled trial. One group had a reintroduction of gluten followed by a wash-out period, then a placebo reintroduction, whereas the other group had the placebo first, then the wash-out and the gluten reintroduction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 22, 2017
• Est. primary completion date: October 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• children with Irritable Bowel Syndrome (IBS)

Exclusion Criteria:

• children with Celiac Disease (CD)

• children with wheat allergy

Related Conditions & MeSH terms

• Celiac Disease
• Diet, Gluten-Free
• Gluten-Sensitive Enteropathy
• Hypersensitivity
• Intestinal Diseases

Intervention

Dietary Supplement:
• gluten

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of IBS	assessed though the composite score of FRANCIS	12 weeks after randomisation
Secondary	change in gastro-intestinal symptoms	assessed by Visual Analog Scale	12 weeks after randomisation
Secondary	Change in quality of life	assessed by PedsQL scale	12 weeks after randomisation